Our Director, Kate Krachai, has been a QP for over 10 years. With her significant expertise and industry experience, Kate, alongside the day to day running of Quality Context, provides support for individuals preparing for their QP viva. Kate’s most recent QP mentoring project was with Brian Alexander who now works at Symbiosis Pharmaceutical Services.

The road to becoming a QP is a long and challenging one. It requires hard work, dedication and substantial training. Once a trainee QP completes all the training modules and they have prepared, or are in the process of preparing, their form for the viva assessment, it is at this point that 1 to 1 mentoring is most beneficial. It is like learning to drive, you can know and learn all the techniques needed to pass but it is only through practice and support that you are able to put yourself forward for the test. The QP viva is an oral exam that lasts between 60-90 minutes where an individual sits in front of a panel of assessors, one from each of the certified bodies. Everything the QP has worked for rests on this.

The purpose of the viva is for the assessors to see what the individual knows and how they will approach real life scenarios. Can the trainee QP draw from all areas of their learning? Have they gained understanding from real life experiences? Do they know the legislation inside out? Will they always put protecting the patient first? Are they able to use and draw upon their network of experts? Will they jump to conclusions? Will they rush decisions or will they be calm, collected and considered?

Scope

Before Brian began working with Kate he already had extensive knowledge of quality and compliance through his industry experience and the training he had already completed.

Brian’s training sessions with Kate consisted of 60 minute Skype calls each month, over a 12 month period. The purpose of these was to help Brian communicate what he already knew and to be aware of the areas he would be examined on.

Kate helped Brian to structure his answers in such a way that he was able to share his knowledge with the panel clearly and concisely. For the viva, Brian would need to continuously consider patient risk in relation to compliance and then explain how he would go about problem solving. Ultimately Kate’s role as his mentor was to give Brian the confidence to say things out loud and to demonstrate being calm and in control. A QP needs to do this every day. To take information, distill it and then communicate it with clarity, all the time thinking about patient safety and ensuring this is at the root of all decision making.

Success

We are delighted that Brian Alexander passed his QP viva, continuing Kate’s 100% pass rate for all the individuals she has worked with.

Brian now works for Symbiosis Pharma Services, a small scale sterile contract commercial and IMP manufacturing business, based in Stirling, UK where he is ensuring the products they manufacture meet the highest levels of quality, are safe and effective, and ultimately protect the safety of patients.

Testimonial

Brian said: “Kate worked with me in preparation for my QP oral assessment. Kate has excellent knowledge of the requirements needed for a trainee QP to be ready for the viva. Kate demonstrated friendly and relaxing training skills which helped me to structure my answers to scenarios and importantly gave me confidence in myself. With Kate’s training and support I passed my viva with excellent feedback from the assessors. I have no hesitation in recommending Kate to any trainee QP in preparing for the oral assessment.”